Device Dossier

Monodek Polydioxanone Monofilament Absorbable Suture - Suture, absorbable

Device Dossier for Monodek Polydioxanone Monofilament Absorbable Suture - Suture, absorbable (Suture, absorbable, Class III, sponsor Boston Scientific).…

Intended purpose

The Monodek Polydioxanone Monofilament Absorbable Suture is indicated for use is soft tissue approximation. It is not indicated in adult cardiovascular tissue, microsurgery or neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to 6 weeks) is desirable.

Functional description

The suture is placed using a needle holder to drive the needle through the tissue. The needle point is then removed and the suture tied using standard surgical procedure. These sutures are gradually encapsulated by fibrous connective tissue before eventually being absorbed by means of hydrolysis. This suture is supplied sterile, dyed (violet) in size 0 (metric size 3.5)in a 48 inch length with a TC tapercut needle. This suture is intended for use with the Capio Suturing Device

TGA Public Summary